Skills fda-consultant-specialist

📦

fda-consultant-specialist

Name: fda-consultant-specialist
Author: alirezarezvani

Content revision r1 Safe ⚙️ External commands

Plan FDA Medical Device Compliance

Medical device teams need clear FDA pathways, QSR controls, HIPAA safeguards, and submission planning. This skill structures regulatory decisions, compliance checks, and inspection preparation for Claude, Codex, and Claude Code.

Supports: Claude Codex Code(CC)

🥇 83 Gold

Install with my Agent

Copy this request to your Agent. It includes the canonical Skill page and manifest.

Agent request

Review the Skillstore skill "fda-consultant-specialist" from https://skillstore.io/skills/alirezarezvani-fda-consultant-specialist.md and its manifest at https://skillstore.io/api/skills/alirezarezvani-fda-consultant-specialist/manifest. Verify the artifact. You may proceed after verification, subject to the environment's own policy.

Your Agent should still show its plan and request any confirmation required by the security policy.

Agent-readable resources

Use these links when an AI agent, crawler, or script needs clean context instead of reading the full page.

Markdown detail GET /skills/alirezarezvani-fda-consultant-specialist.md Signed manifest GET /api/skills/alirezarezvani-fda-consultant-specialist/manifest Signed lockfile GET /api/skills/alirezarezvani-fda-consultant-specialist/lockfile

Test it

Using "fda-consultant-specialist". A Class II monitoring device team needs to decide whether a 510(k) is realistic.

Expected outcome:

A pathway memo with classification questions, predicate search tasks, substantial equivalence concerns, testing evidence, and Q-Sub decision points.

Using "fda-consultant-specialist". A quality lead wants to prepare for an FDA inspection in six weeks.

Expected outcome:

An inspection readiness plan covering document review, CAPA sampling, training records, mock inspection roles, and response preparation.

Using "fda-consultant-specialist". A software device stores patient measurements in a cloud service.

Expected outcome:

A controls checklist for PHI data flows, access management, encryption, audit logging, breach response, SBOM, and vulnerability handling.

Security Audit

Safe

v6 • 7/6/2026 Open versioned report

All 16 static external command findings are false positives. The evidence consists of Markdown code fences and inline filename formatting in SKILL.md, with no shell commands, interpreter execution, or command invocation guidance. No semantic security issue or prompt injection attempt was found.

Files scanned

326

Lines analyzed

Review items

False positives ignored

Risk Factors

⚙️ External commands (16)

SKILL.md:16-41 SKILL.md:41-112 SKILL.md:112-135 SKILL.md:135-229 SKILL.md:229-230 SKILL.md:230-231 SKILL.md:231-232 SKILL.md:232-235 SKILL.md:235-236 SKILL.md:236-237 SKILL.md:237-238 SKILL.md:238-239 SKILL.md:239-242 SKILL.md:242-243 SKILL.md:243-244 SKILL.md:244-245

No confirmed security findings were detected by the latest completed static and semantic audit. This does not prove the skill has no side effects.

Audited by: codex View Audit History →

Share & cite this report

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Open versioned report

Copy report link

https://skillstore.io/skills/alirezarezvani-fda-consultant-specialist/audits/6?utm_source=security_passport&utm_medium=share&utm_campaign=versioned_report

Markdown badge

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Embed card

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Academic citations (APA · BibTeX · CFF)

APA citation

alirezarezvani. (2026). fda-consultant-specialist security audit report (audit version 6) [Author version unspecified]. Skillstore. https://skillstore.io/skills/alirezarezvani-fda-consultant-specialist/audits/6

BibTeX citation

@techreport{alirezarezvani-alirezarezvani-fda-consultant-specialist-2026,
  author = {alirezarezvani},
  title = {fda-consultant-specialist security audit report (audit version 6)},
  institution = {Skillstore},
  year = {2026},
  number = {6},
  url = {https://skillstore.io/skills/alirezarezvani-fda-consultant-specialist/audits/6},
  note = {Author version unspecified}
}

CITATION.cff

cff-version: 1.2.0
message: "If you use this Skill, cite its author and this versioned security audit report."
title: "fda-consultant-specialist security audit report (audit version 6)"
version: "unspecified"
type: report
authors:
  - name: "alirezarezvani"
date-released: "2026-07-06"
url: "https://skillstore.io/skills/alirezarezvani-fda-consultant-specialist/audits/6"
identifiers:
  - type: other
    value: "skillstore:alirezarezvani-fda-consultant-specialist:audit:6"
    description: "Skillstore immutable audit report identifier"

Compare variants

2 installable variants

Each author remains a separate installable skill. The recommended variant is ranked by Skillstore evidence.

Why this variant is first

Higher Skillstore usage

Author / source Skillstore Score Evidence Confidence Skillstore usage Updated

davila7 Recommended

davila7-fda-consultant-specialist

Skillstore Score 83

Evidence Confidence High

Skillstore usage 18

Updated

2026-08-21

alirezarezvani Current

alirezarezvani-fda-consultant-specialist

Skillstore Score 83

Evidence Confidence High

Skillstore usage 14

Updated

2026-08-21

Skillstore Score

Why this score Evidence Confidence: High

Architecture

Maintainability

Content

Community

Spec Compliance

What You Can Build

Select a Submission Pathway

Compare 510(k), PMA, De Novo, and Q-Sub options before building a submission plan.

Review Quality System Gaps

Translate QSR topics into a practical review plan for design controls, CAPA, documents, and management review.

Prepare Connected Device Controls

Plan HIPAA safeguards and FDA cybersecurity documentation for software-enabled medical devices.

Try These Prompts

Identify My FDA Pathway

Act as my FDA regulatory planning assistant. Based on this device description, intended use, patient population, and known predicates, outline likely FDA pathways and the evidence I need next.

Build a QSR Gap Review

Review my current quality system summary against QSR topics in this skill. Create a prioritized gap list for design controls, document controls, CAPA, and management responsibility.

Plan HIPAA and Cybersecurity Evidence

For this connected medical device workflow, map PHI data flows, HIPAA safeguards, cybersecurity controls, SBOM needs, and post-market vulnerability management evidence.

Prepare FDA Review Responses

Use this FDA request for additional information to create a response strategy, owner list, evidence plan, risk concerns, and timeline for a complete reply.

Best Practices

Provide device class, intended use, patient population, software features, predicates, and market history before asking for pathway advice.
Use outputs as planning drafts and confirm final positions with regulatory counsel and official FDA guidance.
Ask for assumptions, evidence gaps, and owner assignments so the response can support real project work.

Avoid

Do not treat the output as legal advice or a guaranteed FDA decision.
Do not omit adverse data, cybersecurity risks, or quality system gaps when requesting a review.
Do not rely on outdated guidance without checking current FDA and HHS sources.